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Sentinel Initiative Public Workshop - Ninth Annual

Event Information
Date
Event Type
Workshop
Description

The Ninth Annual Sentinel Initiative Public Workshop was held on Thursday, February 2, 2017. Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this one-day workshop brought the stakeholder community together to discuss a variety of topics on active medical product surveillance.

Topics included an update on the state of FDA’s Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and accomplishments of the Sentinel System from 2016. In addition, panelists discussed the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities.

Event Materials

Further information and presented materials are available here. 

Information
Host

Mark McClellan MD, PhD; Duke-Robert J. Margolis Center for Health Policy and Robert J. Margolis Professor of Business, Medicine and Health Policy, Duke University

Related Assessment(s)
Sentinel Drug Assessment: Medications for Attention Deficit Hyperactivity Disorder & Heart Failure and Cardiomyopathy
Presenter(s)

Richard Moscicki MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Steven Anderson PhD, MPP; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration 

Gerald J. Dal Pan MD, MHS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 

Gregory Pappas MD, PhD; Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration 

Richard Platt MD, MSc; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA